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Coherus Biosciences announces FDA approved UDENYCA autoinjector

Coherus BioSciences announced that the U.S. Food and Drug Administration, FDA, approved a single-dose, prefilled autoinjector presentation of UDENYCA, a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The UDENYCA autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care. "The UDENYCA autoinjector represents the first innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative solutions that expand access and address the needs of patients undergoing cancer treatment," said Denny Lanfear, CEO of Coherus. Commercial availability of UDENYCA AI is planned for the second quarter of 2023.

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